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Statins could increase the effectiveness of Helicobacter pylori eradication therapies due to their anti-inflammatory effect. The aim of this study was to analyze the impact of this therapeutic association in real life. This is a multicenter, prospective, non-interventional study aimed at evaluating the management of H. pylori by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap from 2013 to 2020. The association between statin use and H. pylori eradication effectiveness was evaluated through multivariate analysis. Overall, 9988 and 705 patients received empirical and culture-guided treatment, respectively. Overall, statin use was associated with higher effectiveness in the empirical group (OR = 1.3, 95%CI = 1.1–1.5), but no association was found with first-line treatment effectiveness (N = 7738), as an exception, statin use was specifically associated with lower effectiveness of standard triple therapy (OR = 0.76, 95%CI = 0.59–0.99). In the rescue therapy empirical group (N = 2228), statins were associated with higher overall effectiveness (OR = 1.9, 95%CI = 1.4–2.6). However, sub-analyses by treatment schemes only confirmed this association for the single-capsule bismuth quadruple therapy (OR = 2.8, 95%CI = 1.3–5.7). No consistent association was found between statin use and H. pylori therapy effectiveness. Therefore, the addition of statins to the usual H. pylori treatment cannot be currently recommended to improve cure rates.

ObjectiveThe best approach for Helicobacter pylori management remains unclear. An audit process is essential to ensure clinical practice is aligned with best standards of care.DesignInternational multicentre prospective non-interventional registry starting in 2013 aimed to evaluate the decisions and outcomes in H. pylori management by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables included demographics, previous eradication attempts, prescribed treatment, adverse events and outcomes. Data monitoring was performed to ensure data quality. Time-trend and geographical analyses were performed.Results30 394 patients from 27 European countries were evaluated and 21 533 (78%) first-line empirical H. pylori treatments were included for analysis. Pretreatment resistance rates were 23% to clarithromycin, 32% to metronidazole and 13% to both. Triple therapy with amoxicillin and clarithromycin was most commonly prescribed (39%), achieving 81.5% modified intention-to-treat eradication rate. Over 90% eradication was obtained only with 10-day bismuth quadruple or 14-day concomitant treatments. Longer treatment duration, higher acid inhibition and compliance were associated with higher eradication rates. Time-trend analysis showed a region-dependent shift in prescriptions including abandoning triple therapies, using higher acid-inhibition and longer treatments, which was associated with an overall effectiveness increase (84%–90%).ConclusionManagement of H. pylori infection by European gastroenterologists is heterogeneous, suboptimal and discrepant with current recommendations. Only quadruple therapies lasting at least 10 days are able to achieve over 90% eradication rates. European recommendations are being slowly and heterogeneously incorporated into routine clinical practice, which was associated with a corresponding increase in effectiveness.

Introduction: Antibiotic resistance is the main factor influencing the ef-ficacy of treatments to eradicate the infection by Helicobacter pylori (H. pylori). The treatments including clarithromycin are the most frequently used in first-line ; however, the bacterial resistance to clarithromycin in treatment-naïve patients in Europe is, overall, >20%.Aims & Methods: To assess the effectiveness of first-line H. pylori treat- ments in Europe according to the resistance to clarithromycin.Non-interventional, prospective, multicenter, international European re-gistry on the management of H. pylori (Hp-EuReg). All culture-diagnosed infected adult patients were registered at AEG-REDCap e-CRF from 2013 to 2021. Per-protocol (PP) analysis was performed based on the presence or absence of bacterial resistance to clarithromycin in treatment-naïve pati-ents. The data was subject to quality control.Results: In total, 2, 479 culture-naïve patients were included. Of these, 627 (25%) reported resistance to clarithromycin. The eradication rate with the standard triple therapy (PPI+clarithromycin+amoxicillin) in patients susceptible to clarithromycin was 92% (424/460). The eradication rate in these clarithromycin-susceptible patients was higher both with the con-comitant regimen (PPI+clarithromycin+amoxicillin+metronidazole) and with the sequential treatment with tinidazole (95%, 882/929), and also with the bismuth quadruple regimen (PPI+bismuth+tetracycline+metronidazole) as single capsule (100%, 67/67) (p

Introduction: Antibiotic resistance is the major factor affecting our ability to cure Helicobacter pylori infection. Quadruple therapy is currently recommended ; however, triple therapy with two antibiotics may be sufficient in those patients without clarithromycin resistance. Aims & Methods: To evaluate the effectiveness of the treatments according to the clarithromycin H. pylori resistance in Europe. International multicenter prospective non-interventional European Registry on H. pylori Management (Hp-EuReg) aiming to evaluate the decisions and outcomes of H. pylori infection. Infected adult patients diagnosed with culture registered at AEG-REDCap e- CRF from 2013 to 2019. Per-protocol (PP) analysis was performed based on the presence or absence of clarithromycin bacterial resistance. Results: Overall, 5, 036 patients were included: 1, 747 (35%) were resistant and 3, 289 (65%) sensitive to clarithromycin. The overall eradication rate was higher in clarithromycin-susceptible patients (91% vs. 84% ; p< 0.001). Triple therapy with a PPI, clarithromycin and amoxicillin achieved over 90% eradication rates in clarithromycin- susceptible patients. However, in those with clarithromycin- resistance, optimal effectiveness was only achieved when treated with quadruple therapy with a PPI, clarithromycin, amoxicillin and bismuth. Conclusion: Classic triple therapy with a PPI, clarithromycin and amoxicillin achieves optimal results (>90%) in patients susceptible to clarithromycin. However, when clarithromycin resistance is unknown, quadruple therapy with a PPI, clarithromycin, amoxicillin and bismuth may be a better treatment option.

Introduction: Antibiotic resistance is the major factor affecting our ability to cure Helicobacter pylori infection. Understanding the different H. pylori antibiotic resistances could be the key to improve treatment effectiveness. Aims & Methods: To evaluate the H. pylori antibiotic resistance both prior and after one or several eradication treatments, in order to provide the most appropriate recommendations for the eradication of H. pylori. International multicenter prospective non-interventional European Regis-try on H. pylori Management (Hp- EuReg) aiming to evaluate the decisions and outcomes of H. pylori infection by European gastroenterologists. Infected adult patients diagnosed with culture and with a result of the antibiotic resistance test registered at AEG- REDCap e-CRF from 2013 to 2019. Per-protocol (PP) analysis was performed. The antibiotic bacterial resistances were described by treatment line. Results: A total of 32, 447 patients were included, and culture was performed in 3, 474 (11%). In naïve patients, 21% reported single clarithromycin resistance, and 11% dual (clarithromycin and metronidazole) resistance. Antibiotic resistance increased markedly from the first treatment, reaching over 37% dual resistance in second-line treatment. Conclusion: In Europe, culture testing to determine antibiotic resistance against H. pylori is scarce. H. pylori single clarithromycin resistance remains high (>15%) in all treatment lines, and greater than 20% in naïve patients. Dual or triple resistances are frequent and increase remarkably after the first treatment failure. Resistance to amoxicillin or tetracycline is exceptional.

Introduction: Bacterial antibiotic resistance changes over time based on multiple factors. It is essential to study these trends to apply preventive strategies to help reducing such resistances.Aims & Methods: To conduct a time-trend analysis of the antibiotic resistance to H. pylori infection in the European Registry on H. pylori (Hp-EuReg). International multicenter prospective non- interventional European Registry on H. pylori Management (Hp-EuReg) aiming to evaluate the decisions and outcomes of H. pylori infection by European gastroenterologists. All infected adult patients diagnosed with culture and with a result of the antibiotic resistance test were registered at AEG-REDCap e-CRF from 2013 to 2019.Results: A total of 32, 447 patients were included, and culture was performed in 3, 474 (11%), where 2, 483 näive patients were included for analysis. Resistance to at least one antibiotic was described in 57% of the patients. Resistance to metronidazole (27%) was most frequent, whereas resistance to tetracycline and amoxicillin was below 1%. Clarithromycin resistance remained above 15% throughout the studied years. A significant decrease in the metronidazole resistance rate was observed between 2013 (38%) and 2018 (21%).Conclusion: In naïve patients, resistance to clarithromycin remained above 15% in the period 2013-2019. A progressive decrease in metronidazole resistance was observed. No increasing or decreasing trend was observed in the bacterial resistance to other antibiotics.

Introduction: The best approach for Helicobacter pylori management remains unclear. An audit process is essential to ensure clinical practice is aligned with best standards of care.Aims & Methods: International multicentre prospective non-interventional registry starting in 2013 aimed to evaluate the decisions and outcomes in H. pylori management by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap up to April 2020. Variables included: demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes. Modified intention-to-treat (mITT) and per-protocol (PP) analyses were performed and data were subject to quality review to ensure information reliability.Results: In total 36, 319 patients from 29 European countries were evaluated and 24, 882 (70%) first-line empirical H. pylori treatments were included for analysis. Triple therapy with amoxicillin and clarithromycin was most commonly prescribed (40%), followed by concomitant treatment (19%) and bismuth quadruple (Pylera®) (10%) achieving 83%, 91% and 95% mITT eradication rate, respectively. Over 90% effectiveness was obtained only with 10 and 14-day bismuth quadruple or 14-day concomitant treatment (Table). Longer treatment duration, higher acid inhibition and compliance were associated with higher eradication rates.Conclusion: Management of H. pylori infection by European gastroenterologists is heterogeneous. Only quadruple therapies lasting at least ten days are able to achieve over 90% eradication rates.

Non-alcoholic fatty liver disease (NAFLD) is a disease characterized by liver steatosis and the ability to progress to more serious pathological conditions, including non-alcoholic steatohepatitis (NASH), fibrosis and cirrhosis of the liver. The progression of the inflammatory process, activation of fibrogenesis and collagen deposition cause the progression of the pathological process and create prerequisites for the occurrence of cirrhosis of the liver, hepatocellular carcinoma. The appearance of fibrosis is considered the most important histological change that determines the subsequent course of NASH. The puncture biopsy of the liver is recognized as the «gold standard for diagnostics» of NASH, including fibrotic changes in the liver. However, the method has a number of limitations due to the high cost and the risk of complications. Therefore, the attention of researchers focused on the search for various non-invasive biomarkers of progression of NAFLD. The latter has a number of common serum biomarkers with cardiovascular diseases, type 2 diabetes mellitus, obesity, and metabolic syndrome. Diagnosis of NAFLD by invasive methods is associated with high material costs and the threat of complications. The literature review presents a list of current biomarkers that can be used to diagnose NAFLD. The diagnostic value of cytokeratin and its combination with other promising biomarkers of steatohepatitis and liver fibrosis are considered. Identification of new serum biomarkers of steatosis and liver fibrosis will ensure timely diagnosis of NAFLD, as well as accurately assess the effectiveness of the prescribed treatment. The NAFLD diagnostic panel using serum biomarkers is minimally invasive, affordable, highly sensitive and specific, which is relevant and economically sound., Неалкогольная жировая болезнь печени (НАЖБП) — это заболевание, характеризующееся стеатозом печени и способностью прогрессировать до более серьезных патологических состояний, в том числе неалкогольного стеатогепатита (НАСГ), фиброза и цирроза печени. Усиление воспалительного процесса, активация фиброгенеза и отложение коллагена обусловливают прогрессирование патологического процесса и создают предпосылки для возникновения цирроза печени и гепатоцеллюлярной карциномы. Появление фиброза считается наиболее важным гистологическим изменением, определяющим последующее течение НАСГ. Золотым стандартом диагностики НАСГ, в том числе фибротических изменений в печени, признана пункционная биопсия печени. Однако метод имеет ряд ограничений, обусловленных высокой стоимостью и риском развития осложнений. Поэтому продолжается поиск неинвазивных биомаркеров прогрессирования НАЖБП. Последняя имеет ряд общих сывороточных биомаркеров с сердечно-сосудистыми заболеваниями, сахарным диабетом 2 типа, ожирением и метаболическим синдромом. Диагностика НАЖБП инвазивными методами сопряжена с высокими материальными затратами и риском развития осложнений. В обзоре литературы приведен перечень современных неинвазивных биомаркеров, которые могут быть использованы для диагностики НАЖБП. Рассмотрена диагностическая ценность цитокератина и его комбинации с другими перспективными биомаркерами стеатогепатита и фиброза печени. Определение новых сывороточных биомаркеров стеатоза и фиброза печени позволит обеспечить своевременную диагностику НАЖБП, а также точно оценивать эффективность назначенного лечения. Диагностическая панель НАЖБП с использованием сывороточных биомаркеров является малоинвазивной, экономически доступной, имеет высокий уровень чувствительности и специфичности., Неалкогольна жирова хвороба печінки (НАЖХП) — це захворювання, яке характеризується стеатозом печінки і здатністю прогресувати до серйозніших патологічних станів, зокрема неалкогольного стеатогепатиту (НАСГ), фіброзу і цирозу печінки. Поглиблення запального процесу, активація фіброгенезу та відкладання колагену зумовлюють прогресування патологічного процесу і створюють передумови для виникнення цирозу печінки та гепатоцелюлярної карциноми. Появу фіброзу вважають найважливішою гістологічною зміною, яка визначає подальший перебіг НАСГ. Золотим стандартом діагностики НАСГ, зокрема фібротичних змін у печінці, визнано пункційну біопсію печінки. Однак метод має низку обмежень, зумовлених високою вартістю і ризиком розвитку ускладнень. Тому триває пошук неінвазивних біомаркерів прогресування НАЖХП. Остання має низку спільних сироваткових біомаркерів із серцево-судинними захворюваннями, цукровим діабетом 2 типу, ожирінням і метаболічним синдромом. Діагностика НАЖХП інвазивними методами пов’язана з високими матеріальними витратами і ризиком розвитку ускладнень. В огляді літератури наведено перелік сучасних неінвазивних біомаркерів, які можуть бути використані для діагностики НАЖХП. Розглянуто діагностичну цінність цитокератину і його комбінації з іншими перспективними біомаркерами стеатогепатиту і фіброзу печінки. Визначення нових сироваткових біомаркерів стеатозу та фіброзу печінки дасть змогу забезпечити своєчасну діагностику НАЖХП, а також точно оцінити ефективність призначеного лікування. Діагностична панель НАЖХП з використанням сироваткових біомаркерів є малоінвазивною, економічно доступною, має високий рівень чутливості та специфічності.